December 2008 Pilot Projects

Three CANNeCTIN pilot projects were approved for funding in the CANNeCTIN December 2008 Pilot Funding Competition:

Heart Failure and Conditioned Nutritional Deficiency in the Myocardium- Malcolm Arnold (University of Western Ontario); $40,000; Heart Failure Working Group

Patients with stable chronic symptomatic systolic HF, on optimized medication, have increased nutritional requirements for I-carnitine, CoQ10, taurine and thiamine that cannot be satisfied by their usual diet. Deficiencies in these nutrients can lead to impaired function of cardiac and perhaps skeletal muscle. Our hypothesis is that a nutritional supplement containing I-carntine, CoQ10, taurine, and thiamine will improve CoQ10 plasma levels, and will also reduce plasma NT-pro brain natriuretic peptide (NT-proBNP) levels, improve cardiac function, 6-minutes walk test (6MWT), NYHA class, and quality of life (QOL). This will be a multicentre study examining the effects of this nutritional supplement in stable symptomatic systolic HF patients. The design will be a pilot study evaluating the patients immediately prior to and after receiving 6 months of supplementation.

The number one cause of disability and the 3rd leading cause of death in patients with atrial fibrillation (AF) is stroke. Echocardiographic studies suggest that the predominant source of stroke in AF is the left atrial appendage (LAA). At present, there are no sufficiently powered trials to answer whether removal of the LAA can reduce the risk of systemic embolic events. The LAAOS trials seek to provide this answer. LAAOS I pilot study will recruit 50 participants undergoing open-heart surgery in 5 Canadian academic cardiac surgery centers. The study will inform the feasibility of conducting a large RCT and will provide information of the efficacy and safety of appendage occlusion technique. Our ultimate aim is to conduct a large international randomized controlled trial (LAAOS II) to determine the impact of left atrial appendage occlusion on the composite outcome of stroke and non-central nervous system systemic embolic events in at risk patients with atrial fibrillation undergoing cardiac surgery.

This is a prospective randomized pilot study to prevent infection in high-risk patients undergoing an arrhythmia device procedure. This will involve 500 patients undergoing a second procedure on an arrhythmia device pocket (generator or lead replacement, pocket or lead revision, upgrade). Patients will be randomized to conventional vs. aggressive prevention of infection, stratified by simple generator change or "complex" procedure. Conservative therapy is a single dose of preoperative intravenous antibiotics compared to aggressive therapy with preoperative intravenous antibiotics, intracavitary antibiotics and postoperative oral antibiotics. Patients and operators will not be blinded. The primary endpoint will be hospitalization attributed to device or lead infection within 12 months of the procedure. Secondary endpoints will include surgically and medically treated infection, antibiotic-related adverse reactions, and a cost analysis. This is a simple study with a one-page baseline data form, and a single summary follow-up at 12 months entered in a web-based data collection interface, with more detailed data collection n the 2% of patients expected to develop the primary endpoint.

Our congratulations to the many investigators, collaborators, and working groups involved in these projects!